MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Express SD Renal/Biliary; stents, drains and dilators for the biliary ducts

Model Number	H74937911715150
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b - pro code (product code): fge, nin.G4 - premarket / 510(k): k152607, k162404, p060006.
Event or Problem Description
It was reported that the stent balloon was difficult to withdraw from the stent requiring additional intervention.A 7.0mmx15mmx150cm express sd renal/biliary balloon expandable stent was used during a renal stenting procedure.The 85% stenosed target lesion was located in a mildly tortuous and severely calcified vessel which was pre-dilated using a 4x15 balloon.Then the express sd stent was placed without any issues; however, the balloon could not be retracted through the 7fr guide catheter and became stuck for 22 minutes.The physician accessed the opposite side, engaged the deployed express sd stent and used a 2x12 balloon to detach the balloon from the stent struts.The balloon was successfully removed from the patient and was fully intact with no part of the balloon remaining in the patients body.There were no patient complications as a result of this event and the patient fully recovered.

• Brand Name: Express SD Renal/Biliary
• Common Device Name: stents, drains and dilators for the biliary ducts
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25638477
• Report Number: 2124215-2026-34259
• Device Sequence Number: 9343986
• Product Code: FGE
• UDI-Device Identifier: 08714729390435
• UDI-Public: (01)08714729390435(17)290322(10)38905955
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74937911715150
• Device Catalogue Number: H74937911715150
• Device Lot Number: 0038905955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown